FDA takes ‘historic action’ on youth e-cigarette ‘epidemic’

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Concerned with an "epidemic" surge in teen use of e-cigarettes, the head of the US Food and Drug Administration announced on Wednesday a "historic action" against more than 1,300 retailers and five major manufacturers for their roles in perpetuating youth access to the devices in the US.

"I use the word epidemic with great care," said FDA commissioner Dr. Scott Gottlieb. "E-cigs have become an almost ubiquitous -- and dangerous -- trend among teens. The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end. It's simply not tolerable."

Gottlieb announced the agency sent 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors under the age of 18, and issued 131 fines to stores that continued to violate the restrictions on sales to minors.

Gottlieb called the action the largest coordinated enforcement effort in the agency's history.

The FDA also requested Juul and four other manufacturers provide plans to mitigate youth sales within 60 days or face potential criminal or civil action, including measures that could allow the agency to remove the manufacturers’ products from store shelves.

The FDA said it would consider requiring brands to remove flavored products, which could be contributing to the rise in youth e-cigarette use.

While the measure is unprecedented, New York City’s acting health commissioner said that it could have been stronger.

“To expect the industry to come up with a plan to curb youth e-cigarette use is like putting the fox in charge of the henhouse,” said Dr. Oxiris Barbot.

She said that while she approves of the FDA’s action, it may prove to be inadequate to address the severity of the situation.

“One of those JUUL cartridges has as much nicotine as an entire pack of cigarettes — not one cigarette, an entire pack,” Dr. Barbot said.

It was news to high schoolers who spoke with PIX11 News, including Icyss Sykes, a Junior at William Cullen Bryant High School in Woodside, Queens.

“That's crazy,” she said in reaction to learning of the high level of the addictive chemical in JUUL-brand e-cigarettes. “Wow, I didn't even know that.”

Sykes, the Junior Class president, said that she doesn’t use e-cigarettes, but that they’re widely used among classmates.

“Students will be walking by, smoking cigarettes in the hallways, not being low-key about it anymore,” she said.

Her friend, Myasia Moreno, a senior at Academy of American Studies high school, described the situation at her school as being at least as serious.

“In classrooms, in the back of the classrooms, wherever you're sitting,” she said. “If your teacher's not looking, [some students are] using them.”

Sykes said that she wants to encourage her school’s administration to educate students about the dangers of JUULs and other e-cigarettes.

“I would like to get Truth,” she said about the industry-funded campaign to educate young people about the dangers of cigarettes and e-cigarettes. “I want to get them to come to the school and talk to children about that, because I think [students] should know that” they’re dangerous and addictive, she told PIX11 News.

The Truth campaign reports that surveys show that many students may not even realize that JUULS are e-cigarettes.

Also, according to the acting health commissioner, since e-cigarettes began to be marketed to New Yorkers under 18, the smoking rate among that demographic has risen to 17 percent. Of that total, five percent of teens are smoking cigarettes. The other 12 percent are using JUULs and other e-cigarettes.

In a statement, Juul Labs said "appropriate flavors" play a role in adults changing their smoking habits, but said it would work with the FDA: "We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people."

It recognized the impact this might have on the use of these products by adults trying to stop smoking, but said that emerging research shows that action must be taken.

"I'll be clear. The FDA won't tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products," Gottlieb said.

Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. Instead, the agency gave extensions to new and existing vaping products, giving them until August 2022 to submit information to support their products' safety and efficacy as switching devices.

The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit.

Wednesday's announcement is part of a series of product standards the agency will roll out as part of their Youth Tobacco Prevention Plan, which they launched earlier this year. The plan will address some of the known public health risks of these products, including the role of flavors.